MIRCETTE Drug Patent Profile

Which patents cover Mircette, and when can generic versions of Mircette launch?

Mircette is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in MIRCETTE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mircette

A generic version of MIRCETTE was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12^th, 1999.

Summary for MIRCETTE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,891
Drug Prices:	Drug price information for MIRCETTE
DailyMed Link:	MIRCETTE at DailyMed

See drug prices for MIRCETTE

See drug sales revenues for MIRCETTE

Recent Clinical Trials for MIRCETTE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3
Teva Branded Pharmaceutical Products, R&D Inc.	Phase 3

See all MIRCETTE clinical trials

US Patents and Regulatory Information for MIRCETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998		DISCN	Yes	No

Expired US Patents for MIRCETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998	4,921,843
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998	RE35724

International Patents for MIRCETTE

See the table below for patents covering MIRCETTE around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	68928897
South Africa	8907977
Finland	103951
Australia	4497089
Australia	620940
Germany	68928897
Portugal	92069	PROCESSO PARA A PRODUCAO DE UM SISTEMA DE DISTRIBUICAO DE DROGAS

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: MIRCETTE

Last updated: August 2, 2025

Introduction

MIRCETTE is a combination oral contraceptive pill that contains ethinylestradiol and drospirenone. Since its launch, it has gained significant market share within the hormonal contraceptive segment, driven by its efficacy, safety profile, and evolving consumer preferences. Understanding the market dynamics and financial trajectory of MIRCETTE entails analyzing its positioning within the broader contraceptive market, regulatory landscape, competitive environment, and financial performance.

Market Overview

The global contraceptive market has exhibited steady growth, driven by increasing awareness of reproductive health, expanding female workforce participation, and shifting societal norms around family planning. According to a report by Market Research Future, the global contraceptive market is expected to expand at a compound annual growth rate (CAGR) of approximately 6% through 2030 [1].

MIRCETTE operates within this expanding segment, competing against both established brands like Yasmin, Yasminelle, and newer oral contraceptives that incorporate innovative formulations or delivery mechanisms. The ascendancy of combination pills like MIRCETTE aligns with consumer preferences for convenience and reliability.

Market Drivers

1. Rising Awareness and Demand for Contraception

Increasing awareness about reproductive health benefits and contraception options has propelled product adoption. Markets in Asia-Pacific and Latin America, in particular, showcase burgeoning demand owing to improving healthcare infrastructure and changing social attitudes.

2. Product Differentiation and Efficacy

MIRCETTE’s specific formulation, combining ethinylestradiol with drospirenone – a spironolactone analog with anti-androgenic properties – offers benefits such as reduced androgenic side effects, leading to enhanced tolerability and fewer adverse effects, which improves patient compliance.

3. Regulatory Approvals and Patent Landscape

Regulatory approvals for oral contraceptives are overall streamlined; however, regulatory agencies like the FDA in the US and EMA in Europe scrutinize safety data meticulously. MIRCETTE's patent family covers its formulation, offering market exclusivity for a specified period, although generic versions threaten pricing pressures once patents expire.

4. Healthcare Policy and Insurance Coverage

In numerous markets, government health policies and insurance reimbursements significantly influence contraceptive uptake. Subsidization programs and policy shifts to promote reproductive health services are anticipated to expand market access.

Competitive Landscape

The contraceptive segment is highly competitive, segmented between branded products, generics, and upcoming innovative modalities (e.g., long-acting reversible contraceptives, implants). Major competitors include Bayer’s Yasmin/Yaz line, Teva’s brands, and emerging generic manufacturers.

MIRCETTE’s differentiation hinges on its safety profile, dosing convenience, and tolerability. Nonetheless, market entrants and generics exert downward pressure on prices and margins.

Regulatory and Legal Environment

Regulatory landscapes vary across regions, impacting MIRCETTE’s commercial trajectory. In markets where patent protection is ending, generic competition intensifies, leading to price erosion. Conversely, new indications, packaging innovations, or combination formulations can extend product lifecycle.

Legal issues such as litigation over side-effects, safety concerns, or patent disputes also influence sales volumes and brand reputation. Continuous pharmacovigilance and regulatory compliance are essential for sustained market presence.

Financial Trajectory

Revenue Streams

MIRCETTE generates revenue primarily through direct sales in managed markets. Market entry costs, marketing expenditure, and distribution logistics comprise the major expenses.

In mature markets, sales volumes tend to plateau, with revenue growth hinging on expanded coverage and competitive positioning. In emerging markets, higher growth rates are possible due to increased acceptance and accessibility.

Pricing Strategy

Pricing remains sensitive to generic competition, reimbursement policies, and consumer affordability. Premium branding can sustain margins in the absence of aggressive price competition; however, overall pricing pressures are pervasive.

Profitability and Cost Structure

Gross margins depend on manufacturing efficiencies, supply chain costs, and pricing. R&D expenses are relatively low for mature contraceptives but escalate during formulation modifications or regulatory filings. Marketing costs significantly influence operational expenses, especially during product launches or repositioning.

Forecasting Financial Performance

Forecasting relies on assumptions about patent expiration timelines, market penetration rates, and regulatory changes. Based on available data, analysts project a moderate increase in sales during the next 2-3 years, plateauing thereafter, barring pipeline advances or lifecycle extensions [2].

Market Challenges and Opportunities

Challenges

• Patent Expiry and Generic Competition: Patent cliffs threaten profit margins, requiring strategic diversification.
• Regulatory Risks: Post-market safety concerns could result in restrictions or label updates.
• Market Saturation in Developed Countries: Slower growth necessitates expansion into emerging markets.
• Societal and Cultural Barriers: Misconceptions and stigmas around contraception may impede market penetration.

Opportunities

• Innovation and Line Extensions: Developing new formulations with additional health benefits.
• Digital Health Integration: Leveraging digital platforms for patient engagement and adherence.
• Strategic Collaborations: Partnerships for distribution, marketing, and research to extend lifecycle.
• Market Expansion: Targeting underpenetrated regions with tailored marketing strategies.

Conclusion

MIRCETTE's market dynamics are shaped by a confluence of rising demand for contraceptives, competitive pressures, regulatory factors, and demographic trends. Its financial trajectory hinges on patent protection, market expansion, and strategic innovation. While facing imminent generic competition, MIRCETTE’s established safety profile and brand recognition sustain its positioning in the hormonal contraceptive sector. Continuous adaptation to market trends and regulatory shifts will determine its long-term financial success.

Key Takeaways

• The global contraceptive market is projected to grow at a CAGR of 6%, fostering favorable conditions for MIRCETTE.
• Patent expiration and generic competition pose significant risk; strategic lifecycle management is essential.
• Product differentiation based on efficacy, safety, and tolerability underpins market positioning.
• Expanding into emerging markets and integrating digital solutions represent vital growth avenues.
• Ongoing regulatory vigilance and innovation are critical for sustaining profitability.

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FAQs

1. How does MIRCETTE compare to other oral contraceptives in terms of safety and efficacy?
MIRCETTE’s combination of ethinylestradiol and drospirenone offers a favorable safety profile, particularly with reduced androgenic side effects, leading to high efficacy in preventing pregnancy and improved tolerability compared to some older formulations.

2. What is the impact of patent expiry on MIRCETTE’s market share?
Patent expiry opens the market to generic competitors, exerting downward pressure on prices and margins. Strategic lifecycle management, including formulation innovations or line extensions, becomes essential to retain market share.

3. Which emerging markets present the best opportunities for MIRCETTE?
Regions like Asia-Pacific, Latin America, and Africa are experiencing rising contraceptive demand due to demographic and socioeconomic factors, offering substantial growth potential for MIRCETTE.

4. What regulatory considerations influence MIRCETTE’s market performance?
Regulatory agencies scrutinize safety, efficacy, and side-effect profiles. Any safety concerns or labeling changes could restrict sales, whereas positive approval processes facilitate market expansion.

5. How can digital health solutions influence MIRCETTE’s future sales?
Digital engagement tools can improve adherence, provide education, and foster brand loyalty, ultimately expanding user base and increasing revenue.

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Sources

[1] Market Research Future. “Contraceptive Market—Forecast to 2030.” 2022.
[2] GlobalData. “Pharmaceuticals & Healthcare Forecasts.” 2023.